Download HEALTHCARE PROFESSIONAL USER GUIDE

HEALTHCARE
PROFESSIONAL
USER GUIDE
In attesa
validazione
versione italiana
Expert guidance on frequently
asked questions
Issue 1: September 2009
3
USERGUIDE
Introducing the COPD Assessment Test™ (CAT)
The COPD Assessment Test (CAT) is a new patient-completed
instrument that has been designed to provide a simple and reliable
measure of health status in COPD. It will complement existing
approaches, such as FEV1 measurement, in assessing COPD patients
by providing a simple method of quantifying the impact of COPD
on the patient’s health.
The CAT has undergone a rigorous, scientific development process
and the first validation studies show that it has properties very similar
to much more complex health status questionnaires such as the
St George’s Respiratory Questionnaire (SGRQ)1 that are used in
research studies. It takes only a fraction of the time to complete,
however, making it suitable for routine use. Further validation studies
are underway in Europe, USA and Asia.
Throughout its development, we have understood from discussions
with primary care physicians, pulmonary specialists and patient groups
from around the world that the precise way the CAT will be used will
vary by healthcare setting and country.
However, we felt that some initial guidance for healthcare professionals
on how to use and interpret CAT scores would be helpful as soon as the
CAT became publicly available. As such we have developed this, the first
edition of the CAT User Guide, which is based upon our current
knowledge of the CAT. In this we include a first method of grading
impact of COPD by CAT scores and provide a simple outline of
potential management considerations/actions. We provide these
broad recommendations with the recognition that these may change
as more evidence becomes available and clinicians gain more experience
with the CAT.
The guide is presented in the form of frequently asked questions in
order to make it as accessible and applicable to your everyday practice
as possible. As we learn more, this guidance will be developed and
refined further.
We look forward to hearing about your experiences using the CAT
in your practice in the near future!
Professor Paul Jones
London, UK
Professor Christine Jenkins
Sydney, Australia
On behalf of the CAT Development Steering Group
Dr Otto Bauerle
Merida, Mexico
USERGUIDE
NOTES
What is the CAT?
The CAT is a validated, short and simple patient-completed
questionnaire which has been developed for use in routine clinical
practice to measure the health status of patients with COPD.
Despite the small number of component items, it covers a broad
range of effects of COPD on patients’ health.
Why has the CAT been developed?
COPD represents a major burden on patients and healthcare systems.
Despite the fact that it is projected to become the third leading cause
of death by 2030,2 communicating the impact of COPD can be difficult
and this can contribute to under-management of COPD in a significant
proportion of people who may suffer increased disability and reduced
quality of life as a result.
The care of COPD patients can only be optimised if there is a reliable,
standardised measure of the overall effect of disease on each
patient’s health.
Unfortunately, commonly used lung function measurements such as FEV1
do not reflect the full impact of COPD.
7
19
USERGUIDE
The COPD Assessment Test (CAT) – the basics
As a result, there is a need for a simple-to-use tool which can measure
the effect of COPD on the patient’s health and enhance understanding
between patients and physicians of the disease’s impact in order to
manage patients optimally and reduce the burden of disease as much
as possible. The CAT has been developed to meet this need.
Development of the COPD
Assessment Test™ (CAT)
How was the CAT developed?
The development of the CAT has involved
well accepted methodologies used to
develop psychometric tools.1,3
The initial item generation
process involved
literature reviews,
physician
interviews and,
most importantly,
patient input.3
TM
TM
A structured, rigorous scientific approach was then used in the item
reduction process to select the best items and generate the final
8-item questionnaire.1
The CAT has been initially validated in prospective studies conducted
in the USA and Europe1 but we believe that it is globally applicable.
A validation study is currently
ongoing in China.
The CAT has been translated
and validated for use in
languages other than English.
Only validated translations
of the CAT should
be used.
For further details on validated translations please visit
www.CATestonline.org
Who developed the CAT?
The CAT was developed by a multidisciplinary group of international
experts who have expertise in developing patient reported outcomes
tools/questionnaires.
The group included pulmonary specialists, primary care physicians and
representatives from patient bodies. Patients with COPD were integral
to the development and validation of the tool. The CAT development
was commissioned and funded by GlaxoSmithKline.
Improving COPD communication, improving care
179
USERGUIDE
NOTESUsing
the CAT in everyday practice: why, who and when
Why should I use the CAT?
Does the CAT replace spirometry?
The CAT is a short, simple questionnaire which is quick and easy for
patients to complete. It provides a framework for discussions with your
COPD patients and should enable you and them to gain a common
understanding and grading of the impact of the disease on their life.
It should also help you to identify where COPD has the greatest effect
on the patient’s health and daily life. As a result you may be better
informed when discussing and making management decisions with
your patients and be able to ensure that his or her health status is as
good as it can be.
No.The CAT is not a diagnostic tool. Spirometry is essential for the
diagnosis of COPD.The CAT and spirometry are complementary
measures which can be used together in the clinical assessment of
a patient’s COPD to ensure that they are being optimally managed.
For which patients is the CAT suitable?
The CAT is suitable for completion by all patients diagnosed with COPD.
Can the CAT be used in all COPD patients irrespective
of disease severity?
Can I use the CAT to diagnose COPD?
No.The CAT is a scientifically developed tool for measurement
of health status. It is not a diagnostic instrument, unlike FEV1
measurement – which is needed to confirm the diagnosis of COPD,
as well as to assess the degree of airway obstruction.
Will the CAT help me make management decisions
regarding any co-morbidities which my COPD patients
may also have?
Yes.The CAT has been developed and validated in COPD patients
of all disease severities as defined by the Global Initiative for Chronic
Obstructive Lung Disease (GOLD).1,3
No.The CAT is a disease-specific tool to measure the impact of COPD
on patients. It will not provide an assessment of co-morbid conditions
or provide information to help guide any management decisions for
co-morbid conditions.
Where and how does the CAT fit into the clinical
assessment of COPD?
How does the CAT compare with other health status
measures used in COPD?
The CAT provides a reliable measure of the impact of COPD on a
patient’s health status.1 It therefore provides supplementary information
to that provided by other aspects of COPD clinical assessment
recommended by current management guidelines (i.e. assessment
of exacerbation risk and degree of airway obstruction, assessed
using spirometry).
The CAT has very similar discriminative properties to the much more
complex SGRQ, suggesting that it will be able to measure the impact
of COPD on the health of individual patients in a similar way.
However, the CAT is much simpler and quicker to complete.
The CAT provides a framework for discussions with your COPD patient
and should enable you and them to gain a common understanding and
grading of the impact of the disease on their life. It should also help you
to identify where COPD affects each patient’s health and daily life most.
As a result you may be better informed in discussing and making
management decisions with them and be able to ensure each of your
COPD patient’s health status is as good as it can be.
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USERGUIDE
Practical use of CAT
When do I give the CAT to my patients to complete?
Experts involved in the development of the CAT recommend that
you ask a COPD patient to complete a CAT questionnaire when
they arrive for a check-up appointment for their COPD or immediately
before attending. Completion of the CAT takes only a couple of
minutes and patients could complete it whilst waiting to see you or
at home prior to consultation.The completed CAT questionnaire
can then provide a framework for your consultation.
Where can I access the CAT questionnaire?
You can download the CAT questionnaire from www.CATestonline.org
Will patients require much instruction to complete
the CAT?
The content of the CAT questionnaire has been driven by COPD
patients. It comprises 8 simple questions that most patients should
be able to understand and answer easily.You should not need to
assist patients to complete it. In fact it is much better if they complete
this independently.
How frequently should the CAT be used in patients?
The optimal frequency for completing the CAT is still to be determined
by actual use in clinical practice. Until further data is available on this,
the expert development committee would recommend that patients
routinely complete the CAT questionnaire every 3-6 months.3
What is the scoring range of the CAT?
The CAT has a scoring range of 0-40.
What do CAT scores and changes in CAT scores mean?
The implication of CAT scores needs to be considered in relation
to an individual’s disease severity. Patients with more severe COPD
(as defined by GOLD) would be expected to have higher CAT scores
than patients with milder disease, although many studies have shown
that the relationship between GOLD stage (measured by FEV1)
and health status scores is generally very weak.4 This is one of the
reasons that the CAT was developed and also why the assessment
of health status and GOLD stage are complementary.
Research is currently ongoing to define ranges of CAT score severity
and to better understand the minimal clinically relevant change
(often referred to as the Minimum Clinically Important Difference
or MCID) in a CAT score from one visit to the next. However, based
on the strong correlation of the CAT with the SGRQ, we currently
believe that a difference or change of 2 or more units suggests a
clinically significant difference or change in health status.We emphasise
that this needs to be confirmed by further scientific studies, but we are
confident that it is a reasonable indicative value of the MCID based
upon current knowledge.
Due to the strong correlation between the CAT and the SGRQ it is
possible to map CAT scores to specific SGRQ items. Four descriptive
scenarios have been developed to provide you with pictures of the type
of patient associated with different levels of CAT score.The content of
these is based solely on the appropriate items in the SGRQ.
They are for illustrative purposes only since each patient will vary in the
way COPD affects him or her, but the scenarios may be useful in
providing you with the broad clinical picture of the impact of COPD
associated with different levels of CAT score.
13
USERGUIDE
In addition, for each scenario, the CAT Development Steering
Group has proposed some potential management considerations:
CAT
score
Impact
level
Broad clinical picture of the impact
of COPD by CAT score
Possible management considerations
>30
Very high
Their condition stops them doing everything
they want to do and they never have any
good days. If they can manage to take a bath
or shower, it takes them a long time.They
cannot go out of the house for shopping or
recreation, or do their housework. Often, they
cannot go far from their bed or chair. They
feel as if they have become an invalid.
Patient has significant room for improvement.
In addition to the guidance for patients with low and medium impact
CAT scores consider:
• Referral to specialist care (if you are a primary care physician)
Also consider:
• Additional pharmacological treatments
• Referral for pulmonary rehabilitation
• Ensuring best approaches to minimising and managing exacerbations
>20
High
COPD stops them doing most things that
they want to do.They are breathless walking
around the home and when getting washed
or dressed. They may be breathless when
they talk.Their cough makes them tired and
their chest symptoms disturb their sleep on
most nights.They feel that exercise is not safe
for them and every thing they do seems too
much effort.They are afraid and panic and do
not feel in control of their chest problem.
10-20
Medium
COPD is one of the most important
problems that they have.They have a few
good days a week, but cough up sputum on
most days and have one or two
exacerbations a year.They are breathless on
most days and usually wake up with chest
tightness or wheeze.They get breathless on
bending over and can only walk up a flight of
stairs slowly.They either do their housework
slowly or have to stop for rests.
Patient has room for improvement – optimise management.
In addition to the guidance provided for patients with low impact
CAT scores consider:
Most days are good, but COPD causes a few
problems and stops people doing one or two
things that they would like to do.They usually
cough several days a week and get breathless
when playing sports and games and when
carrying heavy loads.They have to slow
down or stop when walking up hills or if
they hurry when walking on level ground.
They get exhausted easily.
• Smoking cessation
• Annual influenza vaccination
• Reduce exposure to exacerbation risk factors
• Therapy as warranted by further clinical assessment.
<10
Low
• Reviewing maintenance therapy – is it optimal?
• Referral for pulmonary rehabilitation
• Ensuring best approaches to minimising and managing exacerbations
• Reviewing aggravating factors – is the patient still smoking?
15
USERGUIDE
What effect does an exacerbation have on CAT scores?
We already know that CAT scores in patients with moderate-severe
exacerbations are approximately 5 units higher than in those who are
not exacerbating.1 Based on what we know from other studies, this is
likely to be the size of change in CAT score when a patient gets an
exacerbation. Research studies have shown that it may take many weeks
for patients to recover fully from a single moderate-severe exacerbation
and some patients may never recover fully. Therefore another potential
application of the CAT may be to assess the degree of recovery
following an acute exacerbation by re-assessing the CAT score 2-3
months after the event.
Will I be able to assess response to therapy
with the CAT?
We know that the CAT has good repeatability1, which is similar to that
for the FEV1 and, based upon our current knowledge, we believe that
the relative size of its response to therapy will also be similar to that
of the FEV1. For these reasons, we think that the CAT will be like the
FEV1 – a reliable method of assessing response to therapy in groups of
patients, but less reliable for assessing whether an individual patient has
had a worthwhile response to a specific therapy. That will always require
a thorough individual assessment taking a number of factors into
account – including change in CAT score. However, the CAT will
provide a measure of the individual patient’s health that will be
very useful in initial assessment and for following medium to
long-term trends.
It should also provide a prognostic measure of future health resource
use in individual patients. Data analysis is currently ongoing to confirm
this.The design of the CAT may also allow clinicians to readily identify
areas of a patient’s health that are more severely impaired than others,
such as mood, daytime physical function or sleep.
Can I just use a few of the questions included in the CAT?
No.The CAT should be used in its entirety.The CAT was validated as
an 8-item questionnaire and the questions should not be split up or
used independently of each other. This will reduce the integrity and
measurement properties of the questionnaire. However, responses to
the individual items can be used to provide you with an indication of
the areas of the patient’s health that are more affected than others.
For example, one patient may have higher scores for cough and sputum,
whereas another may have highest scores for the items about activity
or sleep.
Is the CAT free to use?
Yes.The CAT will be available and free to use globally (no charges will
be associated with its use).
Is the CAT available in different languages?
Yes.The CAT will be available in different languages. However, only
approved translations of the CAT questionnaire should be used to
ensure the validity and measurement properties of the questionnaire
are maintained. For further details on validated translations please
visit www.CATestonline.org
References
1. Jones PW, Harding G, Berry P, et al. Development and first validation of the COPD
Assessment Test. Eur Respir J 2009; 34: 648-54.
2. World Health Statistics 2008. ISBN 978 92 4 156359 8 (NLM classification: WA
900.1); ISBN 978 92 4 0682740 (electronic version).
http://www.who.int/respiratory/copd/World_Health_Statistics_2008/en/print.html
3. Jones PW. Harding G, Wiklund I, et al. Improving the process and outcome of care in
COPD: development of a standardised assessment tool. Prim Care Resp J 2009; 18
(3): 208-15.
4. Jones PW. Health status measurement in chronic obstructive pulmonary disease.
Thorax 2001; 56: 880-7.
179
USERGUIDE
NOTESUsing
the CAT in everyday practice: why, who and when
Why should I use the CAT?
Does the CAT replace spirometry?
The CAT is a short, simple questionnaire which is quick and easy for
patients to complete. It provides a framework for discussions with your
COPD patients and should enable you and them to gain a common
understanding and grading of the impact of the disease on their life.
It should also help you to identify where COPD has the greatest effect
on the patient’s health and daily life. As a result you may be better
informed when discussing and making management decisions with
your patients and be able to ensure that his or her health status is as
good as it can be.
No.The CAT is not a diagnostic tool. Spirometry is essential for the
diagnosis of COPD.The CAT and spirometry are complementary
measures which can be used together in the clinical assessment of
a patient’s COPD to ensure that they are being optimally managed.
For which patients is the CAT suitable?
The CAT is suitable for completion by all patients diagnosed with COPD.
Can the CAT be used in all COPD patients irrespective
of disease severity?
Can I use the CAT to diagnose COPD?
No.The CAT is a scientifically developed tool for measurement
of health status. It is not a diagnostic instrument, unlike FEV1
measurement – which is needed to confirm the diagnosis of COPD,
as well as to assess the degree of airway obstruction.
Will the CAT help me make management decisions
regarding any co-morbidities which my COPD patients
may also have?
Yes.The CAT has been developed and validated in COPD patients
of all disease severities as defined by the Global Initiative for Chronic
Obstructive Lung Disease (GOLD).1,3
No.The CAT is a disease-specific tool to measure the impact of COPD
on patients. It will not provide an assessment of co-morbid conditions
or provide information to help guide any management decisions for
co-morbid conditions.
Where and how does the CAT fit into the clinical
assessment of COPD?
How does the CAT compare with other health status
measures used in COPD?
The CAT provides a reliable measure of the impact of COPD on a
patient’s health status.1 It therefore provides supplementary information
to that provided by other aspects of COPD clinical assessment
recommended by current management guidelines (i.e. assessment
of exacerbation risk and degree of airway obstruction, assessed
using spirometry).
The CAT has very similar discriminative properties to the much more
complex SGRQ, suggesting that it will be able to measure the impact
of COPD on the health of individual patients in a similar way.
However, the CAT is much simpler and quicker to complete.
The CAT provides a framework for discussions with your COPD patient
and should enable you and them to gain a common understanding and
grading of the impact of the disease on their life. It should also help you
to identify where COPD affects each patient’s health and daily life most.
As a result you may be better informed in discussing and making
management decisions with them and be able to ensure each of your
COPD patient’s health status is as good as it can be.
199
USERGUIDE
NOTESUsing
Thethe
COPD
CATAssessment
in everyday
As a result, there is a need for a simple-to-use tool which can measure
the effect of COPD on the patient’s health and enhance understanding
between patients and physicians of the disease’s impact in order to
manage patients optimally and reduce the burden of disease as much
as possible. The CAT has been developed to meet this need.
Development of the COPD
Assessment Test™ (CAT)
How was the CAT developed?
The development of the CAT has involved
well accepted methodologies used to
develop psychometric tools.1,3
The initial item generation
process involved
literature reviews,
physician
interviews and,
most importantly,
patient input.3
Test
practice:
(CAT)
why,–who
the basics
and when
TM
Does the CAT replace spirometry?
No.The CAT is not a diagnostic tool. Spirometry is essential for the
diagnosis of COPD.The CAT and spirometry are complementary
measures which can be used together in the clinical assessment of
a patient’s COPD to ensure that they are being optimally managed.
Can I use the CAT to diagnose COPD?
No.The CAT is a scientifically developed tool for measurement
of health status. It is not a diagnostic instrument, unlike FEV1
measurement – which is needed to confirm the diagnosis of COPD,
as well as to assess the degree of airway obstruction.
Will the CAT help me make management decisions
regarding any co-morbidities which my COPD patients
may also have?
No.The CAT is a disease-specific tool to measure the impact of COPD
on patients. It will not provide an assessment of co-morbid conditions
or provide information to help guide any management decisions for
co-morbid conditions.
How does the CAT compare with other health status
measures used in COPD?
The CAT has very similar discriminative properties to the much more
complex SGRQ, suggesting that it will be able to measure the impact
of COPD on the health of individual patients in a similar way.
However, the CAT is much simpler and quicker to complete.
USERGUIDE
USERGUIDE
HEALTHCARE
PROFESSIONAL
USER GUIDE
Introducing the COPD
The COPD Assessment Test (CAT) is a new patient-completed
instrument that has been designed to provide a simple and reliable
measure of health status in COPD. It will complement existing
approaches, such as FEV1 measurement, in assessing COPD patients
by providing a simple method of quantifying the impact of COPD
on the patient’s health.
The CAT has undergone a rigorous, scientific development process
and the first validation studies show that it has properties very similar
to much more complex health status questionnaires such as the
St George’s Respiratory Questionnaire (SGRQ)1 that are used in
research studies. It takes only a fraction of the time to complete,
however, making it suitable for routine use. Further validation studies
are underway in Europe, USA and Asia.
Throughout its development, we have understood from discussions
with primary care physicians, pulmonary specialists and patient groups
from around the world that the precise way the CAT will be used will
vary by healthcare setting and country.
Improving COPD communication,
improving care
www.CATestonline.org
Supported by an educational grant
from GlaxoSmithKline
COPD Assessment Test and CAT logo is a trademark of the
GlaxoSmithKline group of companies.
© 2009 GlaxoSmithKline. All rights reserved.
C/09/134 Date of preparation: September 2009
Expert guidance on frequently
asked questions
Issue 1: September 2009